Rocuronium Bromide (Rocuronium Bromide)

Trade Name : Rocuronium Bromide

Hikma Pharmaceuticals USA Inc.

INJECTION

Strength 10 mg/mL

ROCURONIUM BROMIDE Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rocuronium Bromide (Rocuronium Bromide) which is also known as Rocuronium Bromide and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 10 mg/mL per ml. Read more

Rocuronium Bromide (Rocuronium Bromide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Dosage and Administration
u00a0u00a0u00a0 Important Dosing and Administration Information ()u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 11/2018
Warnings and Precautions
u00a0u00a0u00a0 Risk of Death due to Medication Errors ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a011/2018

Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Rocuronium Bromide is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. ()

Individualize the dose for each patient. ()
Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery. ()
Store Rocuronium Bromide Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ()
Tracheal intubation
Rapid sequence intubation
Maintenance doses
Continuous infusion

Rocuronium Bromide Injection is available as

5 mL multiple dose vials containing 50 mg Rocuronium Bromide Injection (10 mg/mL). ()
10 mL multiple dose vials containing 100 mg Rocuronium Bromide Injection (10 mg/mL). ()

Rocuronium Bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents .

Hypersensitivity (e.g., anaphylaxis) to Rocuronium Bromide or other neuromuscular blocking agents. ()

No data

Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. ()
Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents. ()
Risk of Death due to Medication Errors: Accidental administration can cause death ()
Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation. ()
Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur. ()

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension.
The following adverse reactions are described, or described in greater detail, in other sections:
Most common adverse reactions (2%) are transient hypotension and hypertension. ()
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Succinylcholine: Use before succinylcholine has not been studied. ()
Nondepolarizing muscle relaxants: Interactions have been observed. ()
Enhanced Rocuronium Bromide activity possible: Inhalation anesthetics (), certain antibiotics (), quinidine (), magnesium (), lithium (), local anesthetics (), procainamide ()
Reduced Rocuronium Bromide activity possible: Anticonvulsants. ()

No data

Labor and Delivery: Not recommended for rapid sequence induction in patients undergoing Cesarean section. ()
Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients. ()

Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent.
Arrayn- Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended.
Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e.g., 5-second head lift, adequate phonation, ventilation, and upper airway patency. Ventilation must be supported while patients exhibit any signs of muscle weakness.
Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances the management is the same as that of prolonged neuromuscular blockade.

Rocuronium Bromide Injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17u03b2-(acetyloxy)-3u03b1-hydroxy-2u03b2-(4-morpholinyl)-5u03b1-androstan-16u03b2-yl]-1-(2-propenyl)pyrrolidinium bromide.
The structural formula is:
The chemical formula is CHBrNO with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20u00b0C.
Rocuronium bromide is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide.

No data

Studies in animals have not been performed with rocuronium bromide to evaluate carcinogenic potential or impairment of fertility. Mutagenicity studies (Ames test, analysis of chromosomal aberrations in mammalian cells, and micronucleus test) conducted with rocuronium bromide did not suggest mutagenic potential.

In US clinical studies, a total of 1137 patients received Rocuronium Bromide, including 176 pediatric, 140 geriatric, 55 obstetric, and 766 other adults. Most patients (90%) were ASA physical status I or II, about 9% were ASA III, and 10 patients (undergoing coronary artery bypass grafting or valvular surgery) were ASA IV. In European clinical studies, a total of 1394 patients received Rocuronium Bromide, including 52 pediatric, 128 geriatric (65 years or greater), and 1214 other adults.

Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only.
Rocuronium Bromide Injection is available in the following:
u00a0The container closure of this drug product does not contain natural rubber latex.
Rocuronium Bromide Injection should be stored in a refrigerator, 2u00ba to 8u00baC (36u00ba to 46u00baF). DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25u00baC/77u00baF), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days.
Arrayn- Safety and Handling:

Obtain information about your patient's medical history, current medications, any history of hypersensitivity to Rocuronium Bromide or other neuromuscular blocking agents. If applicable, inform your patients that certain medical conditions and medications might influence how Rocuronium Bromide works.
In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide, have been reported. Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents.
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Manufactured by:n
Distributed by:
Revised November 2018
PIN452-WES/4
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NDC 0143-9250-01n n n (10 mg/mL)n n n n n n Rx ONLYn
Apply to syringeRocuroniumBromide Injection10 mg/mLFor Intravenous Use Onlyu00a0u00a0u00a0u00a0u00a0 Rx ONLYPARALYZING AGENT

NDC 0143-9251-01n n n n n n n n n n Rx ONLYn
Apply to syringeRocuroniumBromide Injection10 mg/mLFor Intravenous Use Onlyu00a0u00a0u00a0u00a0u00a0 Rx ONLYPARALYZING AGENT

No data

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Rocuronium Bromide (Rocuronium Bromide)

Trade Name : Rocuronium Bromide

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Rocuronium Bromide (Rocuronium Bromide)

Trade Name : Rocuronium Bromide

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

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NZ Drugs

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